Aevi Genomic Medicine’s share price crashes 75% following ADHD trial failure
Aevi Genomic Medicine, a US drugmaker based outside of Philadelphia, has seen its share value plummet by 75% following the failure of its experimental attention deficit hyperactivity disorder (ADHD) drug to meet its primary endpoint in the treatment of children between the ages of six and seventeen.
AEVI-001, as the orally-administered candidate is known, was shown to be unable to reduce ADHD Rating Scale (ADHD-RS) scores in forms of the condition with an mGluR copy number variant (Part A) or without an mGluR copy number variant (Part B) to a statistically significant degree after six weeks of treatment. Sixty-nine participants were enrolled for Part A of the study, while 109 were enrolled for Part B.
However, despite the failure, the company did note that the candidate was found to be safe and well-tolerated, with minimal reports of adverse events across either treatment group.
The drug also failed to reduce ADHD-RS scores in adolescent patients with mGluR mutation-positive ADHD back in 2017. With the release of these disappointing new data, Aevi stressed that it was still committed to the development of AEVI-001 in ADHD patient sub-populations with genetic mutations that disrupt the mGluR network.
“We are very disappointed that the ASCEND trial did not achieve its primary endpoint,” said Michael F Cola, CEO of Aevi Genomic Medicine. “We plan to conduct a full review of the data with our scientific advisers in the coming days and consider our options.”
He added: “We remain committed to our mission of bringing novel targeted therapies to children with serious rare and orphan disease. We will continue to focus on our pipeline of additional molecules, including AEVI-002 for severe paediatric-onset Crohn’s Disease and AEVI-005 for an undisclosed autoimmune orphan disease, both partnered with Kyowa Hakko Kirin. In the near-term, we anticipate reducing the scope of our operations to preserve our net working capital, which was approximately $5 million (unaudited) as of December 31, 2018.”
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